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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982-09-06 - 1982-09-17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: Environmental Protection Agency (EPA) Paragraph 163. 81-5 "Primary eye irritation study". Federal Register, Vol. 43 No. 163, August 22, 1978
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:3)
EC Number:
279-506-0
EC Name:
6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:3)
Cas Number:
80584-92-5
Molecular formula:
C21H36N6O6.3C6H15NO3
IUPAC Name:
6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:3)
Details on test material:
- Physical state: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, 4414 Fuellinsdorf, Switzerland
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages
- Diet: ad libitum (Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, Switzerland)
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 55±15
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Adjacent eye served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
Duration of treatment / exposure:
In 3 of 6 rabbits approx. 30 sec after the treatment the treated eye was rinsed. The other three rabbits stayed treated until the end of the observation period.
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: 3 out of 6 rabbits were rinsed with 10 mL physiological saline.
- Time after start of exposure: 30 seconds

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 , 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Eye was not rinsed.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: Eye was not rinsed.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 , 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Eye was rinsed.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 , 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: Eye was rinsed.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 , 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: Eye was not rinsed.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48 , 72 hours
Score:
0.66
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: Eye was not rinsed.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 , 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: Eye was not rinsed.
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 24, 48 , 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: Eye was rinsed.
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 24, 48 , 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: Eye was rinsed.
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 24, 48 , 72 hours
Score:
0.66
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: Eye was rinsed.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 , 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Eye was not rinsed.
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 , 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Eye was not rinsed.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 , 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Eye was not rinsed.
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 24, 48 , 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Eye was rinsed.
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: 24, 48 , 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Eye was rinsed.
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: 24, 48 , 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Eye was rinsed.
Irritant / corrosive response data:
Minimal irritation was observed in the unrinsed eye.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met